About this trial
Total knee arthroplasty (TKA) is one of the most frequently performed elective orthopaedic procedures. Following hospital discharge, patients must manage pain, wound care and home rehabilitation with limited professional support. This pragmatic randomised pilot trial will evaluate whether a web-based conversational postoperative assistant, used in addition to standard care, improves patient satisfaction and exercise adherence during the first 6 weeks after TKA. Forty to sixty patients undergoing primary elective TKA will be randomised 1:1 to standard care with or without access to the conversational assistant. The primary outcome is overall patient satisfaction at 6 weeks. Secondary outcomes include pain intensity, exercise adherence, unplanned healthcare contacts and postoperative complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Primary, unilateral, elective total knee arthroplasty (TKA).
Discharged to home following surgery.
Ability to use a smartphone or tablet with internet access (patient or caregiver).
Disqualifiers
Revision or bilateral simultaneous TKA.
Major postoperative complication precluding home discharge (e.g., admission to intensive care, unplanned return to theatre, or haemodynamic instability).
Severe cognitive impairment precluding informed consent or device use.
No access to an internet-enabled device.
Trial design
Parallel
Treatments tested in this trial
Web-based conversational postoperative assistant
BehavioralParticipants assigned to the intervention group receive access to a web-based conversational assistant for 6 weeks after primary total knee arthroplasty. The assistant provides evidence-based postoperative education, recovery guidance, answers to common patient questions, and safety-oriented recommendations. It is available on demand and complements, but does not replace, standard postoperative care.
Treatment groups
Trial outcomes
Primary outcomes
Overall Patient Satisfaction
Overall patient satisfaction measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates not satisfied at all and 10 indicates completely satisfied.
Secondary outcomes
Pain Intensity
Pain intensity measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Exercise Adherence
Exercise adherence assessed as the percentage of prescribed home exercise sessions completed, based on the participant's exercise diary.
Unplanned Healthcare Contacts
Number of unplanned healthcare contacts related to the operated knee, including primary care visits, emergency department visits, outpatient consultations, and hospital readmissions.
Postoperative Complications
Occurrence of postoperative complications related to the surgical procedure.
Sponsors and contacts
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Wojciech Sroga
Lead sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor institution
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